One of the most widely used methods of medical therapy is the intravenous (IV) infusion of medicaments and/or nutrients into the bloodstream of a patient. A familiar apparatus that is used in many IV infusion applications is the IV bag. The IV bag contains the fluid to be infused into the patient. Typically, one end of an IV line is attached to the IV bag in communication with the fluid in the IV bag, and the other end of the IV line is connected to a needle that can puncture the patient to thereby establish a path for fluid communication from the IV bag to the patient. Usually, the bag is elevated above the patient to establish a positive pressure head to force the fluid that is within the bag into the patient.
Accordingly, an IV bag must have at least one opening through which fluid can flow. Many IV bags, however, have more than a single opening, to establish both a pathway for extracting fluid from the bag and a pathway for injecting fluid into the bag. Specifically, many bags have one or more openings in the bottom seam of the bag, and tubes are respectively connected to the openings. Each tube has a membrane disposed therein. In one application, the membrane can be pierced by inserting a so-called IV spike into the tube. The spike is usually connected to a drip chamber and the drip chamber in turn is connected to the IV line to the patient. The spike must ordinarily remain connected to the tube until the contents of the bag have been exhausted because the membrane is not resealable when the spike is extracted from the tube.
In another application, a resealable membrane is provided in the tube, and the resealable membrane can be punctured by the needle of a syringe to inject additional fluid from the syringe into the bag. After fluid injection, the needle can be withdrawn, and the membrane reseals to prevent fluid flow through the opening.
In addition to the openings in its bottom seam, an IV bag can have an opening in its sides or top seam. A pierceable resealable membrane can be positioned in each of the openings, and the needle of a syringe can be advanced through the membrane. Fluid in the syringe can then be injected into or extracted from the bag through the needle. After fluid injection or extraction, the needle can be withdrawn from the bag, at which time the membrane reseals. When such an arrangement is on the side of the container, the arrangement is colloquially known as a "belly button."
Unfortunately, each of the arrangements mentioned above has certain drawbacks. For example, the arrangements that are used with syringes require the use of a sharpened needle or spike to pierce the respective membranes. The use of sharpened needles and spikes, however, raises the possibility that a health care worker could inadvertently puncture the bag or himself with the needle or spike. Besides being uncomfortable for the health care worker, the specter of transmitting infectious diseases via the needle or spike is raised by such mishaps, which can have tragic consequences, particularly in the era of AIDS. Thus, the use of needles and other "sharps" should be avoided whenever possible in the health care environment.
While a spike is ordinarily not considered to be a "sharp," the existing membrane arrangements requiring the use of a spike do not permit removal of the spike from the bag Until the contents of the bag are completely exhausted. This is because the hole a spike makes in a membrane is typically too large to permit the membrane to reseal. Thus, once inserted, a spike is not usually removed from an IV bag until the bag is empty, which can understandably limit use of the bag.
Accordingly, it is an object of the present invention to provide an IV bag which does not require the use of "sharps" to infuse or extract fluid from the bag and which has tamper-resistant connector ports. Another object of the present invention is to provide an IV bag that permits the removal of a set from the bag before the bag is empty, with the option of recapping the bag. Yet another object of the present invention is to provide an IV bag that is easy to use and cost-effective to manufacture.